The Effect of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response(POR)

Poor Ovarian Response Clinical Trial

Official title:

A Randomized and Double-blind Clinical Trial of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089395
• Other study ID #: JJGS on POR
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Dongzhimen Hospital, Beijing
• Contact: Shi Y Shi Yun, phD
• Phone: 13717926522
• Email: zhyshiyun[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Relying on the Department of Gynecology of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine and chaoyang hospital of Capital medical university, this randomized controlled clinical study was carried out to investigate the application of kidney tonifying herbs to patients with poor ovarian response（POR）. A total of 76 patients with POR were collected and stratified district groups were randomly divided into a test group and a control group, with 38 patients included in each group. The experimental group was intervented with JJGS granules + coenzyme Q10 simulant, and the control group was intervened with coenzyme Q10 + JJGS granules simulant. AMH, serum basal sex hormone, AFC, TCM syndrome score, modified Kupperman scale and pregnancy status were observed before and after treatment to investigate the effects of Jiajian Guishen granules on the ovarian function of POR patients.

Description:

This study was a multicenter, stratified block randomized, double-blind, double simulation, positive controlled clinical trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Woman who meet the diagnostic criteria for poor ovarian response;

2. Woman who meet the TCM diagnostic criteria for kidney deficiency;

3. Woman whose serum basal FSH(two consecutive menstrual cycles)between 10-25mIU/mL

4. Woman whose AMH <1.1ng/ml;

5. Woman aged ranged from 20-45 years old

6. Woman whose body mass index (BMI)<35 kg/m2

7. Womanwho voluntarily signed the informed consent form.

Exclusion Criteria:

1. Woman who have combination of serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems, and malignant tumors;

2. Woman who have other endocrine diseases, such as polycystic ovary syndrome and hyperprolactinemia;

3. Woman who are unable to cooperate with the treatment and follow-up, such as combined neurological and psychiatric disorders, or those who are unwilling to cooperate.

4. Woman who have used the same efficacy of herbs or other therapies in the last 1 month;

5. Woman who are allergic to the drugs used in this study.

Related Conditions & MeSH terms

• Poor Ovarian Response

Intervention

Drug:
• Jiajian Guishen granules
This study was a stratified district group randomized, double-blind, double simulation, positive control clinical trial with JJGS granules + coenzyme Q10 simulant in the test group and JJGS granules simulant + coenzyme Q10 in the control group
• coenzyme Q10
This study was a stratified district group randomized, double-blind, double simulation, positive control clinical trial with JJGS granules + coenzyme Q10 simulant in the test group and JJGS granules simulant + coenzyme Q10 in the control group

Locations

Country	Name	City	State
China	Chaoyang Hospital Affiliated to Capital Medical University	Beijing
China	Dongzhimen Hospital of Beijing University of Chinese Medicine	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Shi Yun	Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Miller's Tube Hormone(AMH)	The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, anti-mullerian hormone (AMH) was measured by radioimmunoassay	before treatment and the first menstrual period 2-4 days after treatment
Secondary	Follicle-stimulating hormone(FSH)	The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, FSH were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Secondary	Luteinizing hormone(LH)	The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, LH were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Secondary	Estrogen (E2)	The unit is pg/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, E2 were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Secondary	Progesterone (P)	The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, P were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Secondary	Testosterone(T)	The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, T were measured by radioimmunoassay.	before treatment and the first menstrual period 2-4 days after treatment
Secondary	antral follicle count(AFC)	Color Doppler ultrasound was performed in the early follicular phase in the usual way to observe the number of follicles in the underlying sinuses.	before treatment and early follicular phase in the first post-treatment menstrual cycle day 1
Secondary	Traditional Chinese Medicine Score	The main symptoms include menstrual cycle, menstrual flow reduction. Scoring criteria: ? normal menstrual cycle 0 points, 1-2 weeks ahead or behind the wrong 4 points, 2-3 weeks 8 points, more than 3 weeks 12 points; ? menstrual flow than the previous menstrual flow no change 0 points, menstrual flow reduction = ? 4 points, ? < menstrual flow reduction = ½ 8 points, menstrual flow reduction > ½ 12 points. Secondary symptoms included lumbar and knee pain, dizziness and tinnitus, loss of libido, increased urination, hot flashes and night sweats, and lower back and lower limb pain. According to the degree of aggravation of symptoms, the total score was assigned as 0,2,4,8. The sum of the scores of the main symptoms and secondary symptoms, the higher the score, the more serious the TCM symptoms.	baseline and immediately after treatment
Secondary	Modified Kupperman rating scale	Referring to the domestic modified Kupperman Symptom Scoring Criteria in Chinese Obstetrics and Gynecology, edited by Cao Zeyi, to observe and rate perimenopausal symptoms before and after treatment and to quantify the degree of decline in ovarian function.Entries include hot flashes and sweating, sensory abnormalities, insomnia, anxiety and depression, dizziness, fatigue, muscle and joint pain, headache, palpitations, ankylosis of the skin, sexual discomfort, and urinary irritation, with different coefficients for each entry, and according to the aggravating degree of the symptom, they are divided into 0, 1, 2, and 3 points, and the coefficients corresponding to the scoring of the degree of each item are multiplied by a fixed score of the symptom to add up to the total score, and the higher the total score suggests that the symptoms of the perimenopausal period are more serious.	baseline and immediately after treatment
Secondary	Clinical pregnancy rate	Defined as the number of women with identified clinical pregnancies divided by the number of patients randomized to a specific group. Clinical pregnancy is confirmed when 1 or more ges-tational sacs are detected on transvaginal ultrasound assessment.	up to 6 months
Secondary	Early miscarriage rate	Defined as the per-centage of participants with loss of a diagnosed clinical pregnancy before 12 weeks gestation to the total patients randomized	up to 6 months